In devices normally used for applications of this sort, mechanical massage of the skin is performed using revolving bodies of various forms (rollers, balls), often rotated electronically, or by vibration of appropriately shaped rigid surfaces, or using variously shaped hollow bodies in which a vacuum is formed.
In U.S. Pat. No. 6,196,982, massaging is performed using a vacuum which draws a portion of the skin onto an elastomeric surface which, subjected to the action of a vibration-generating device, performs the desired massage.
The principles on which the device in U.S. Pat. No. 6,196,982 is based, however, fail to provide for effective, vigorous skin massage.
One of the characteristics of the device according to the present invention is a membrane, in particular an elastomeric membrane.
The membrane replaces the rigid bodies which, as stated, usually revolve, and which, when set in motion, produce the actual massage effect of known devices.
The membrane used in the invention may be of varying rigidity, e.g. depending on the thickness and type of elastomeric material employed, and, while providing for softer contact with the skin as compared with rigid elements of any form, has projections or recesses on its outer surface enabling it to exert significant pressure on the skin.
More specifically, the membrane in the present invention is fixed along the edge of a chamber forming part of a handset, and, in addition to lifting a portion of skin, is moved back and forth by a variable vacuum generated by a vacuum pump, and the pattern of which may be determined, for example, by opening and closing two electronically controlled solenoid valves.
The membrane also has holes by which to also transmit the vacuum to the skin, once sufficient airtight sealing is achieved by pressing the raised edge of the membrane lightly on the patient's skin. One or more folds are thus formed in the skin and kneaded by alternating suction on the membrane, which also has tissue-folding projections and recesses.
Another characteristic of the present invention is that of employing a vacuum device capable, in particular, of performing pulsating skin treatment cycles.
By virtue of various preset treatment programs, defects can therefore be treated specifically according to the degree of advancement and the area of the body involved. Effects range from remodelling, with or without weight loss, combined with improved physical appearance and skin tone, to a reduction in body dimensions. The present invention is also designed for physiotherapy and rehabilitation in the treatment of traumas and connective tissue diseases, and is also so effective in improving arterial-venous and lymphatic microcirculation as to cure lymphoedemas and poor microcirculation.
In the present invention, employing a pneumatic circuit for producing a controlled vacuum is instrumental in enabling automatic mechanical massage. In the known art, direct contact between the suction source and the skin is potentially dangerous, and may result in pain and irritation by sharp exposure of the skin tissue to the vacuum.
Interfacing the patient's body exclusively by means of the membrane, however, reduces pain caused by suction, and prevents direct contact between the skin and the vacuum chamber.
The handset can be moved manually over the tissue portion for treatment, after first coating the patient's skin with oil or other lubricating means.
As the handset slides over the skin, the tissue portion adhering to the membrane is therefore raised, folded, smoothed and compressed vigorously according to the program selected by the operator, so that the tissue is modelled and transferred in a wavelike motion, with beneficial effects at connective tissue layer level.
Revolving bodies or vibrating surfaces, such as those of known devices, also pose a serious hygiene problem, by being fixed and therefore used for different patients. Apart from the time factor involved, thorough, continual disinfection of such parts is also technically complex, by frequently involving automatic mechanical devices.
Conversely, the membrane used in the present invention is easily replaceable, and may therefore be changed for each patient.
To ensure the utmost hygiene, it is therefore proposed that the membrane be used once, and may be changed after each treatment. In other words, the membrane may be disposable and made of non-allergenic, easily disinfectable material.
Another drawback of known marketed devices is that of only performing mechanical treatment, with no regard to other equally straightforward, controllable forms of tissue treatment. Particularly interesting is the possibility of combining the effects of the massage element with those of an ultrasound device, thus exploiting, not only the purely mechanical action performed by the membrane, but also the known mechanical, thermal, chemical and cavitational effects produced by ultrasound on biological tissue.
The device according to the present invention is an electric medical device for performing in-depth, non-invasive mechanical massage, which, by the combined action of suction and the membrane with specially shaped projections, lifts and manipulates the skin and subcutaneous tissue, and is specially designed to simulate the so-called “knead-and-roll” manual massage method widely used by physiotherapists and masseurs.
The physiological effects produced by the device according to the present invention are as follows.
The tissues for treatment are “separated” by suction and immediately subjected to vigorous mechanical massage, which stimulates venous and lymphatic circulation of the treatment area, thus improving cutaneous and subcutaneous nutrition, and in particular provides for reabsorbing stagnant liquids and mobilizing subcutaneous fat. Recent findings, in fact, show that even light mechanical stress is sufficient to break down fat cells, which release triglycerides and fatty acids, and are distributed evenly over a much wider area. The main effect is that of stimulating tissue metabolism and vascularization, followed by lymph drainage and tissue purification, the latter assisted by the high degree of mobility of the fluid inside the tissue.
The device according to the present invention greatly increases subcutaneous flood flow, by the mechanical massage action being directed locally on the treatment area.
The most significant histological change induced by the mechanical massage performed by the device is the accumulation of longitudinal collagen bands in the subcutaneous tissue. This is accompanied by some deformation of the fat cells, and both the above architectural variations occur with no inflammation or repair reaction. Redistribution of the vertical force component, by longitudinal collagen bands depositing parallel to the skin surface, and breakdown of the vertical fascia fibres assist in reducing the appearance of cellulite in the treated tissue.
Ultrasound action is also extremely important, and is combined with that of the massage membrane in one embodiment of the present invention. The interaction of ultrasound with biological tissue produces various effects, as described in detail below.
Therapeutically, ultrasound provides mainly for pain relief, muscle relaxation, and fibrolytic and nutrition effects. These are due partly to the increase in temperature produced by absorption of viscosity-related heat, in turn produced by thermal conductivity and chemical absorption, and partly to mechanical micromassage of the tissue.
The increase in temperature also has a vasodilatory effect, which assists catabolite removal and supplies the tissue with nutritional substances and oxygen. Ultrasound thus improves tissue nutrition, assists in repairing damaged tissue, and accelerates resolution of inflammation processes.
Ultrasound oscillation of the tissue particles breaks up the collagen fibres of fibrous tissue. Dispersion and separation of the collagen fibres and softening of the cement are used to assist reabsorption of organized haematomas and to soften tissue; which effects, together with an overall feeling of well-being, make ultrasound ideal for the purpose in question.
Another advantage of the present invention is that, according to recent studies, ultrasound attenuation is reduced alongside an increase in skin deformation, as a result of collagen fibre redistribution. Combined with mechanical massage, ultrasound therefore provides for greater in-depth massage of the treated tissue.